Osstell SmartPeg Type 115 08086147

GUDID 09010522002605

ISQ Measurement Peg

Osstell AB

Dental implant stability resonance frequency analysis peg

• Primary Device ID: 09010522002605
• NIH Device Record Key: 7c5079fa-30c2-4d1e-a39b-cd982f9d535e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osstell SmartPeg Type 115
• Version Model Number: Osstell SmartPeg Type 115
• Catalog Number: 08086147
• Company DUNS: 633171269
• Company Name: Osstell AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09010522002605 [Package]; Contains: 09010522002612; Package: Box [5 Units]; In Commercial Distribution
GS1	09010522002612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181888

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-04
• Device Publish Date: 2025-03-27

Devices Manufactured by Osstell AB

• 09010522002650 - Osstell Beacon Instrument: 2025-10-06 ISQ Measurement Instrument
• 09010522002667 - MEGA ISQ II Instrument: 2025-10-06 ISQ Measurement Instrument
• 09010522002551 - Osstell SmartPeg Type 112: 2025-04-04 ISQ Measurement Peg
• 09010522002568 - Osstell SmartPeg Type 113: 2025-04-04 ISQ Measurement Peg
• 09010522002582 - Osstell SmartPeg Type 114: 2025-04-04 ISQ Measurement Peg
• 09010522002605 - Osstell SmartPeg Type 115: 2025-04-04ISQ Measurement Peg
• 09010522002605 - Osstell SmartPeg Type 115: 2025-04-04 ISQ Measurement Peg
• 09010522002636 - Osstell Classic Instrument: 2025-03-31 ISQ Measurement Instrument
• 09010522000731 - Osstell ISQ Probe: 2024-09-19 ISQ Measurement Instrument Accessory